The eligibility of Lifeward’s ReWalk Personal Exoskeleton under the Nairobi Protocol treatment from Israel

N355678 November 25, 2025 CLA-2-98:OT:RR:NC:N3:135 CATEGORY: Classification TARIFF NO.: 9817.00.96 Brett Harris Roll & Harris LLP 2001 L Street, NW, Suite 500 Washington, DC 12561 RE: The eligibility of Lifeward’s ReWalk Personal Exoskeleton under the Nairobi Protocol treatment from Israel Dear Mr. Harris: In your letter dated November 3, 2025, you requested a tariff classification ruling on behalf of your client, Lifeward Inc. The product under consideration is Lifeward’s ReWalk Personal Exoskeleton, which is a wearable robotic exoskeleton (bionic walking assistance system) that provides powered hip and knee motion to enable individuals with a spinal cord injury to stand upright, walk, turn, and climb and descend stairs. The system provides user-initiated mobility through the integration of a wearable brace support, a computer-based control system, motion sensors, a wrist-mounted remote, and forearm crutches. It allows independent, controlled walking while mimicking the natural gait patterns of the legs. You state the design, form, and use of the exoskeleton make it easily distinguishable from articles useful to non-handicapped persons. The device is only useful to those who have lost the use of their legs and the ability to walk, and has no characteristics that would create a probability of use by members of the general public who are not suffering from a severe spinal cord injury. The exoskeletons are manufactured and imported by Lifeward, a medical device company, that specializes in technologies to enable mobility and wellness in rehabilitation for individuals with physical and neurological conditions. The ReWalk Personal Exoskeleton is not sold in retail outlets for the general public. Rather, these articles are sold directly to handicapped individuals who require them. You claim that at the time of entry, all parts of the exoskeleton are clearly and unequivocally designed for use by individuals unable to walk and are suitable for no other use. You confirm that the ReWalk Personal Exoskeleton is not an article for the treatment of an acute or transient disability. It is designed for the use of paraplegics who have lost complete use of their legs – a permanent handicap. It will last a person’s entire life and is by no means temporary. In your submission you requested consideration of a classification under 9817.00.96, Harmonized Tariff Schedule of the United States (HTSUS), which applies to articles and parts and accessories of articles specifically designed or adapted for the use or benefit of the permanently or chronically physically or mentally handicapped. Subheading 9817.00.96, HTSUS, covers: “Articles specially designed or adapted for the use or benefit of the blind or other physically or mentally handicapped persons; parts and accessories (except parts and accessories of braces and artificial limb prosthetics) that are specially designed or adapted for use in the foregoing articles . . . Other.” The term “blind or other physically or mentally handicapped persons” includes “any person suffering from a permanent or chronic physical or mental impairment which substantially limits one or more major life activities, such as caring for one’s self, performing manual tasks, walking, seeing, hearing, speaking, breathing, learning, or working.” U.S. Note 4(a), Subchapter XVII, Chapter 98, HTSUS. Subheading 9817.00.96, HTSUS, excludes “(i) articles for acute or transient disability; (ii) spectacles, dentures, and cosmetic articles for individuals not substantially disabled; (iii) therapeutic and diagnostic articles; or, (iv) medicine or drugs.” U.S. Note 4(b), Subchapter XVII, Chapter 98, HTSUS. In Sigvaris, Inc. v. United States, 227 F. Supp 3d 1327, 1336 (Ct. Int’l Trade 2017), aff’d, 899 F.3d 1308 (Fed. Cir. 2018), the U.S. Court of International Trade (CIT) explained that “specially” means “to an extent greater than in other cases or towards others” and “designed” means something that is “done, performed, or made with purpose and intent often despite an appearance of being accidental, spontaneous, or natural.” We must first evaluate “for whose, if anyone’s, use and benefit is the article specially designed,” and then, whether “those persons [are] physically handicapped [].” Sigvaris, 899 F.3d at 1314. The Court of Appeals for the Federal Circuit (CAFC) clarified in Sigvaris, 899 F.3d at 1314-15 that to be “specially designed,” the merchandise “must be intended for the use or benefit of a specific class of persons to an extent greater than for the use or benefit of others” and adopted the five factors used by U.S. Customs and Border Protection (CBP): (1) the physical properties of the article itself (i.e., whether the article is easily distinguishable by properties of the design, form, and the corresponding use specific to this unique design, from articles useful to non-handicapped persons); (2) whether any characteristics are present that create a substantial probability of use by the chronically handicapped so that the article is easily distinguishable from articles useful to the general public and any use thereof by the general public is so improbable that it would be fugitive; (3) whether articles are imported by manufacturers or distributors recognized or proven to be involved in this class or kind of articles for the handicapped; (4) whether the articles are sold in specialty stores which serve handicapped individuals; and, (5) whether the condition of the articles at the time of importation indicates that these articles are for the handicapped. Based on the information provided, the ReWalk Personal Exoskeleton is specially designed for the use or benefit of paraplegic persons who have lost the ability to walk. These persons are physically handicapped as their permanent physical impairment substantially limits one or more major life activities, such as walking. As such, it qualifies for duty-free treatment under subheading 9817.00.96, HTSUS. The tariffs and additional duties cited above are current as of this ruling’s issuance. Duty rates are provided for your convenience and are subject to change. The text of the most recent HTSUS and the accompanying duty rates are provided at https://hts.usitc.gov/. The holding set forth above applies only to the specific factual situation and merchandise description as identified in the ruling request. This position is clearly set forth in Title 19, Code of Federal Regulations (CFR), Section 177.9(b)(1). This section states that a ruling letter is issued on the assumption that all of the information furnished in the ruling letter, whether directly, by reference, or by implication, is accurate and complete in every material respect. In the event that the facts are modified in any way, or if the goods do not conform to these facts at time of importation, you should bring this to the attention of U.S. Customs and Border Protection (CBP) and submit a request for a new ruling in accordance with 19 CFR 177.2. Additionally, we note that the material facts described in the foregoing ruling may be subject to periodic verification by CBP. This ruling is being issued under the provisions of Part 177 of the Customs and Border Protection Regulations (19 C.F.R. 177). A copy of the ruling or the control number indicated above should be provided with the entry documents filed at the time this merchandise is imported. If you have any questions regarding the ruling, please contact National Import Specialist Fei Chen at fei.chen@cbp.dhs.gov. Sincerely, (for) Deborah Marinucci Designated Official Performing the Duties of the Division Director National Commodity Specialist Division